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Study of Efficacy and Safety of Canakinumab in Japanese Patients With SJIA

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Juvenile Idiopathic Arthritis

Intervention: Canakinumab (Biological)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Overall contact:
Novartis Pharmaceuticals, Phone: +81337978748

Summary

This is a phase III study designed to provide efficacy and safety data for canakinumab administered for at least 48 weeks as subcutaneous (s. c.) injection every 4 weeks (q4wk) in Japanese patients with Systemic Juvenile Idiopathic Arthritis (SJIA). Interim analysis (IA) data at Week 28 and 48 from this study will support a registration submission of canakinumab in the indication of SJIA in Japan.

Clinical Details

Official title: An Open-label, Single-arm, Active-treatment, Efficacy and Safety Study of Canakinumab (ACZ885) Administered for at Least 48 Weeks in Japanese Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Proportion pf patients who achieved a minimum adapted ACR Pediatric 30 criteria

Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully

Secondary outcome:

Proportion of patients who met the adapted ACR Pediatric 30/50/70/90/100 criteria of canakinumab over time

Change from baseline in components of the adapted ACR pediatric criteria of canakinumab over time

Proportion of patients who had flares with canakinumab treatment over time

Proportion of patients who achieved inactive disease (with and without duration of morning stiffness) with canakinumab treatment over time

Changes from baseline in CRP levels with canakinumab treatment over time

Proportion of patients with canakinumab treatment who were able to taper corticosteroids successfully over time

Corticosteroids dose reduction with canakinumab treatment over time

Number and percentage of patients with adverse events

Percentage of patients with notable abnormalities in laboratory parameters newly occurred after baseline

Percentage of patients with notable abnormalities in vital sign newly occurred after baseline

Serum concentration of canakinumab and total IL-1 beta

Immunogenicity of canakinumab

Eligibility

Minimum age: 2 Years. Maximum age: 19 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Confirmed diagnosis of SJIA as per ILAR definition (Petty, et al. 2004) that must have

occurred at least 3 months prior to enrollment with an onset of disease < 16 years of age: Arthritis in one or more joints, with or preceded by fever of at least 2 weeks duration that is documented to be daily/quotidian for at least 3 days and accompanied by one or more of the following: Rash due to SJIA,lymphadenopathy, Hepatomegaly/Splenomegaly, Serositis

- Active disease at the time of baseline defined as follows:

- At least 2 joints with active arthritis

- Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day

during the screening epoch and within 1 week before first canakinumab dose

- CRP > 30 mg/L(3 mg/dL) (normal range < 10 mg/L(1 mg/dL))

- Negative TB screen (Chest X-ray and T-SPOT test)

Exclusion Criteria:

- With active or recurrent bacterial, fungal or viral infection at the time of

enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection. Patients with resolved/previous hepatitis B infection (a negative HBs antigen, but a positive anti-HBs antibody and/or anti-HBc antibody).

- With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions

which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.

- With neutropenia (absolute neutrophil count < 1500/mm3) at screening.

Locations and Contacts

Novartis Pharmaceuticals, Phone: +81337978748

Novartis Investigative Site, Obu-city, Aichi 474-8710, Japan; Not yet recruiting

Novartis Investigative Site, Kobe-city, Hyogo 654-0081, Japan; Not yet recruiting

Novartis Investigative Site, Kanazawa-city, Ishikawa 920-8641, Japan; Recruiting

Novartis Investigative Site, Kagoshima-city, Kagoshima 890-8520, Japan; Recruiting

Novartis Investigative Site, Yokohama-city, Kanagawa 232-8555, Japan; Not yet recruiting

Novartis Investigative Site, Yokohama-city, Kanagawa 236-0004, Japan; Not yet recruiting

Novartis Investigative Site, Sendai-city, Miyagi 989-3126, Japan; Recruiting

Novartis Investigative Site, Bunkyo-ku, Tokyo 113-8603, Japan; Not yet recruiting

Additional Information

Starting date: May 2015
Last updated: May 5, 2015

Page last updated: August 23, 2015

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